March 11, 2021
Sun Pharmaceutical Industries Inc. is recalling a single lot of Cequa (cyclosporine) ophthalmic solution 0.09% due to subpotency, according to the March 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Cequa 0.09%, 60 single-use vials (6 pouches x 10 single-use vials [0.25 mL each], NDC 47335-506-96), manufactured for Sun Pharma Global FZE by Laboratoire Unither, Coutances, France, from lot 10007 (Exp. 1/22). The vials were distributed in the United States and Australia.
Sun Pharmaceutical Industries voluntarily initiated the recall February 22, 2021. The FDA designated the recall Class III on February 26, 2021. Under the recall classification, use of the recalled product is not likely to cause harm.
Cequa is a prescription calcineurin inhibitor immunosuppressant used to increase tear production in patients with dry eye.